Lee S. Schwartzberg, MD: We talked a little bit about unmet needs. Let’s talk some more about that. So, how do we get at this nausea problem? The CINV field has basically looked at complete response as the endpoint. Complete response is a construct for our audience, defined as no emesis and no use of rescue medication in 5 days. That’s how we define success from a regulatory perspective. That’s not how we define the success from taking care of patients.

Eric Roeland, MD: And people should recognize why. I think when you’re trying to have a study and you want to show endpoints, you want something that you can measure. I think that’s really where that came from. Complete response being no vomiting, which you can measure, and not using those medicines, which you can also measure, but that’s not necessarily what is patient centered or patient focus.

Lee S. Schwartzberg, MD: So, can we measure nausea? What do you think?

Lee S. Schwartzberg, MD: As Charles said, maybe our bar should be no nausea. Some studies use no significant nausea. But, what does that mean? It means marking on a visual analog scale less than 25 out of 100.

Rebecca Clark-Snow, RN, BSN, OCN: Unfortunately, I think nausea is going to be here to stay for a while until we come up with that perfect drug that takes care of everything.

Lee S. Schwartzberg, MD: Right. But, we do have about 70% control for the AC, and probably a little higher for platinum. So, there’s still a residual 30%, 40% there.

Charles L. Loprinzi, MD: Well, I think it’s a bit more on the nausea. If you go 5 days with no nausea, with the standard 3-drug regimen, it’s probably more like 30%. But, can we measure it? I think, yes, we can measure it, just like we can measure pain—what the patient says —and it can be differentiated from being hungry or not being hungry. And, just like we can measure hot flashes by asking, do you have hot flashes or not? Study after study after study show that with the same drug, it works the same. So, yes, these are measurable things. It’s not perfect. But, again, Rudy Navari has been the main person pushing this same thing. No nausea is probably the best thing, if you can get no nausea.

Lee S. Schwartzberg, MD: So, you’re an expert in measuring subjective findings from patients. Can you measure differences between patient groups? Even if nausea is interpreted a little different, can you measure a benefit? Is the benefit similar in a different patient whether they experience nausea a little different if you see a percentage benefit? In other words, a drug helps a particular condition.

Charles L. Loprinzi, MD: I think if you have groups of patients, you can measure these things. But, for individual patients, it could be harder. As a group, yes, and I think that studies that have looked at this, showing similar results with different groups of patients. So, yes. But, each individual patient might have a different perspective and you’re not going to get 100% on things. I think you can measure changes in pain, hot flashes, mouth sores, all these things. Patient reported outcome is the new terminology for many, many of these things, and that’s what it is. And it’s best for them to write it down daily as opposed to trying to summarize it 2 weeks later by talking to the doctor or the nurse.

James Natale, PharmD, BCOP: I always worry about scales like nausea, just the variability, even in regions. In certain offices, you just see different responses from nausea in a 50 to 60 miles/hour rate or radius.

Lee S. Schwartzberg, MD: Do you think that’s conditioning of patients or do you think that’s a different population?

James Natale, PharmD, BCOP: I don’t know.

Lee S. Schwartzberg, MD: We do see that these trials that are run globally, we see differences from different parts of the world. That may be cultural, and it may be physiologic and pharmacogenomic. We just don’t know the answer to that yet.

Charles L. Loprinzi, MD: You need to make sure you’re measuring the same way, how you ask the question.

Eric Roeland, MD: I think Charles mentioned the multi-day regimen, which is huge. We don’t know if you’re even getting low or moderate emetogenic chemotherapy for several days in a row, if that should be treated by just taking the worst offender of those and making sure your prophylaxis is treated that way. And then, how often do you dose them? I think a huge unmet need in that setting are hematologic malignancies. These are patients who frequently are getting that multi-day regimen. And when you ask our transplanters, there’s a wide variation on how they’re approaching this issue.

James Natale, PharmD, BCOP: And, they’re always on the drugs that interact with these agents, as well.

Eric Roeland, MD: Bingo.

Lee S. Schwartzberg, MD: And not to denigrate that group, but when you think about what are you focused on, for a transplanter it’s about giving the drugs and getting the right therapy in. It’s not so much about supportive care, right? So, it’s been a little bit neglected.

Charles L. Loprinzi, MD: Although, there was an abstract presented at this meeting on early palliative care for patients getting transplant versus standard care, illustrating that their symptoms were better controlled when you had somebody who’s focused on that. When the transplant doctors focus on trying to cure the cancer and somebody else focuses on that, you do have better quality of life and better symptom control in that setting, too.

Lee S. Schwartzberg, MD: That just extends what we already know: early palliative care is better for everyone, right? And that’s for whether you have an advanced cancer, you’re curative, or even in the palliative setting, as we know.

Charles L. Loprinzi, MD: Yes.

Rebecca Clark-Snow, RN, BSN, OCN: Well, I think what’s been another unmet need for a very, very long time is for our pediatric patients. Recently, Emend has been approved for pediatric patients, and there are more studies that are being conducted, fortunately, for pediatric patients now to help them. It’s been more than 30 years really. They’re not little human beings, since we’ve been treating them as such with what’s been available.

Lee S. Schwartzberg, MD: Right. And we don’t have any pediatric oncologists on the panel today, but I’m glad you brought that up because it is clearly an unmet need. Many of the drugs that they receive in very aggressive curative regimens are highly emetogenic. We definitely need more studies there.

Rebecca Clark-Snow, RN, BSN, OCN: We do.

Lee S. Schwartzberg, MD: Also, radiation, I think, is an unmet need, particularly as we do more combined modality therapy. So, seeing some studies now around that is important as well.

Rebecca Clark-Snow, RN, BSN, OCN: I think we also mentioned the high-dose chemotherapy and the conditioning for patients who are about to undergo transplantation. That’s a difficult group of patients to treat as well.

Transcript Edited for Clarity

Transcript:

Lee S. Schwartzberg, MD: We talked a little bit about unmet needs. Let’s talk some more about that. So, how do we get at this nausea problem? The CINV field has basically looked at complete response as the endpoint. Complete response is a construct for our audience, defined as no emesis and no use of rescue medication in 5 days. That’s how we define success from a regulatory perspective. That’s not how we define the success from taking care of patients.

Eric Roeland, MD: And people should recognize why. I think when you’re trying to have a study and you want to show endpoints, you want something that you can measure. I think that’s really where that came from. Complete response being no vomiting, which you can measure, and not using those medicines, which you can also measure, but that’s not necessarily what is patient centered or patient focus.

Lee S. Schwartzberg, MD: So, can we measure nausea? What do you think?

Lee S. Schwartzberg, MD: As Charles said, maybe our bar should be no nausea. Some studies use no significant nausea. But, what does that mean? It means marking on a visual analog scale less than 25 out of 100.

Rebecca Clark-Snow, RN, BSN, OCN: Unfortunately, I think nausea is going to be here to stay for a while until we come up with that perfect drug that takes care of everything.

Lee S. Schwartzberg, MD: Right. But, we do have about 70% control for the AC, and probably a little higher for platinum. So, there’s still a residual 30%, 40% there.

Charles L. Loprinzi, MD: Well, I think it’s a bit more on the nausea. If you go 5 days with no nausea, with the standard 3-drug regimen, it’s probably more like 30%. But, can we measure it? I think, yes, we can measure it, just like we can measure pain—what the patient says —and it can be differentiated from being hungry or not being hungry. And, just like we can measure hot flashes by asking, do you have hot flashes or not? Study after study after study show that with the same drug, it works the same. So, yes, these are measurable things. It’s not perfect. But, again, Rudy Navari has been the main person pushing this same thing. No nausea is probably the best thing, if you can get no nausea.

Lee S. Schwartzberg, MD: So, you’re an expert in measuring subjective findings from patients. Can you measure differences between patient groups? Even if nausea is interpreted a little different, can you measure a benefit? Is the benefit similar in a different patient whether they experience nausea a little different if you see a percentage benefit? In other words, a drug helps a particular condition.

Charles L. Loprinzi, MD: I think if you have groups of patients, you can measure these things. But, for individual patients, it could be harder. As a group, yes, and I think that studies that have looked at this, showing similar results with different groups of patients. So, yes. But, each individual patient might have a different perspective and you’re not going to get 100% on things. I think you can measure changes in pain, hot flashes, mouth sores, all these things. Patient reported outcome is the new terminology for many, many of these things, and that’s what it is. And it’s best for them to write it down daily as opposed to trying to summarize it 2 weeks later by talking to the doctor or the nurse.

James Natale, PharmD, BCOP: I always worry about scales like nausea, just the variability, even in regions. In certain offices, you just see different responses from nausea in a 50 to 60 miles/hour rate or radius.

Lee S. Schwartzberg, MD: Do you think that’s conditioning of patients or do you think that’s a different population?

James Natale, PharmD, BCOP: I don’t know.

Lee S. Schwartzberg, MD: We do see that these trials that are run globally, we see differences from different parts of the world. That may be cultural, and it may be physiologic and pharmacogenomic. We just don’t know the answer to that yet.

Charles L. Loprinzi, MD: You need to make sure you’re measuring the same way, how you ask the question.

Eric Roeland, MD: I think Charles mentioned the multi-day regimen, which is huge. We don’t know if you’re even getting low or moderate emetogenic chemotherapy for several days in a row, if that should be treated by just taking the worst offender of those and making sure your prophylaxis is treated that way. And then, how often do you dose them? I think a huge unmet need in that setting are hematologic malignancies. These are patients who frequently are getting that multi-day regimen. And when you ask our transplanters, there’s a wide variation on how they’re approaching this issue.

James Natale, PharmD, BCOP: And, they’re always on the drugs that interact with these agents, as well.

Eric Roeland, MD: Bingo.

Lee S. Schwartzberg, MD: And not to denigrate that group, but when you think about what are you focused on, for a transplanter it’s about giving the drugs and getting the right therapy in. It’s not so much about supportive care, right? So, it’s been a little bit neglected.

Charles L. Loprinzi, MD: Although, there was an abstract presented at this meeting on early palliative care for patients getting transplant versus standard care, illustrating that their symptoms were better controlled when you had somebody who’s focused on that. When the transplant doctors focus on trying to cure the cancer and somebody else focuses on that, you do have better quality of life and better symptom control in that setting, too.

Lee S. Schwartzberg, MD: That just extends what we already know: early palliative care is better for everyone, right? And that’s for whether you have an advanced cancer, you’re curative, or even in the palliative setting, as we know.

Charles L. Loprinzi, MD: Yes.

Rebecca Clark-Snow, RN, BSN, OCN: Well, I think what’s been another unmet need for a very, very long time is for our pediatric patients. Recently, Emend has been approved for pediatric patients, and there are more studies that are being conducted, fortunately, for pediatric patients now to help them. It’s been more than 30 years really. They’re not little human beings, since we’ve been treating them as such with what’s been available.

Lee S. Schwartzberg, MD: Right. And we don’t have any pediatric oncologists on the panel today, but I’m glad you brought that up because it is clearly an unmet need. Many of the drugs that they receive in very aggressive curative regimens are highly emetogenic. We definitely need more studies there.

Rebecca Clark-Snow, RN, BSN, OCN: We do.

Lee S. Schwartzberg, MD: Also, radiation, I think, is an unmet need, particularly as we do more combined modality therapy. So, seeing some studies now around that is important as well.

Rebecca Clark-Snow, RN, BSN, OCN: I think we also mentioned the high-dose chemotherapy and the conditioning for patients who are about to undergo transplantation. That’s a difficult group of patients to treat as well.